Bimagrumab + Semaglutide for Obesity

Recruiting in Palo Alto (17 mi)

+63 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Eli Lilly and Company

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing whether bimagrumab alone or with semaglutide can help overweight or obese men and women keep or increase their muscle mass while losing weight. Bimagrumab helps build or maintain muscle, and semaglutide helps reduce appetite and promote weight loss. Bimagrumab is a new agent with a unique way of working.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

Adults aged 18-80 who are overweight or obese (BMI ≥ 30, or BMI ≥ 27 with related health issues like high blood pressure) can join. They must have tried to lose weight before without success and be willing to follow the study's diet and activity plans. Women able to have children need two negative pregnancy tests and must use an IUD plus a barrier method for contraception.

Inclusion Criteria

A written informed consent must be obtained before any study-related assessments are performed

History of at least one self-reported unsuccessful behavioral effort to lose body weight

Body mass index (BMI) ≥ 30 or BMI ≥ 27 with one or more obesity-associated comorbidities

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Exclusion Criteria

I am allergic to some specific drug types or cannot take semaglutide.

I do not have chronic infections like HBV, HCV, or HIV.

I haven't taken any obesity medication in the last 30 days.

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Treatment Details

Interventions

Bimagrumab (Monoclonal Antibodies)
Semaglutide (GLP-1 Receptor Agonist)

Trial OverviewThe trial is testing Bimagrumab alone or combined with Semaglutide against a placebo in men and women who are overweight or obese. It aims to find out how effective these treatments are at helping participants lose weight, as well as their safety profiles.

Participant Groups

9Treatment groups

Experimental Treatment

Placebo Group

Group I: Placebo + semaglutide 2.4 mgExperimental Treatment2 Interventions

Participants will receive i.v. placebo at baseline and at Weeks 4, 16, 28 and 40, 52 and 64, and s.c. semaglutide 2.4 mg weekly per the dose escalation schedule.

Group II: Placebo + semaglutide 1.0 mgExperimental Treatment2 Interventions

Participants will receive i.v. placebo at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 1.0 mg weekly per the dose escalation schedule.

Group III: Bimagrumab 30 mg/kg + semaglutide 2.4 mgExperimental Treatment2 Interventions

Participants will receive i.v. bimagrumab 30 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 2.4 mg per the dose escalation schedule.

Group IV: Bimagrumab 30 mg/kg + semaglutide 1.0 mgExperimental Treatment2 Interventions

Participants will receive i.v. bimagrumab 30 mg/kg at baseline, and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 1.0 mg weekly per the dose escalation schedule.

Group V: Bimagrumab 30 mg/kg + no semaglutideExperimental Treatment1 Intervention

Participants will receive i.v. bimagrumab 30 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64.

Group VI: Bimagrumab 10 mg/kg to bimagrumab 30 mg/kg + no semaglutideExperimental Treatment1 Intervention

Participants will receive i.v. bimagrumab 10 mg/kg at baseline and at Weeks 4, 16, 28 and 40 during the core treatment period and will switch during the extension period to receive bimagrumab 30 mg/kg at Weeks 52 and 64.

Group VII: Bimagrumab 10 mg/kg + semaglutide 2.4 mgExperimental Treatment2 Interventions

Participants will receive i.v. bimagrumab 10 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 2.4 mg weekly per the dose escalation schedule.

Group VIII: Bimagrumab 10 mg/kg + semaglutide 1.0 mgExperimental Treatment2 Interventions

Participants will receive i.v. bimagrumab 10 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 1.0 mg weekly per the dose escalation schedule.

Group IX: Placebo to bimagrumab 30 mg/kg + no semaglutidePlacebo Group2 Interventions

Participants will receive i.v. placebo at baseline and at Weeks 4, 16, 28 and 40 during the core treatment period and will switch during the extension period to receive bimagrumab 30 mg/kg at Weeks 52 and 64.